Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals

Katherine M. Knapp, Susan B. Brogly, Daniel G. Muenz, Hans M L Spiegel, Daniel H. Conway, Gwendolyn B Scott, Jeffrey T. Talbot, David E. Shapiro, Jennifer S. Read

Research output: Contribution to journalArticle

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Abstract

Background: Although use of efficacious interventions, including antiretrovirals (ARVs), has dramatically reduced the rate of mother-to-child transmission of human immunodeficiency virus, the safety of in utero ARV exposure remains of concern. Methods: Data regarding 1112 infants enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025 born between 2002 and 2007 were analyzed for this study. Congenital anomalies were classified based on the Metropolitan Atlanta Congenital Defects Program guidelines. Associations between congenital anomalies and timing of first in utero exposure to ARVs were evaluated by logistic regression analysis. Results: Congenital anomalies were identified and confirmed in 61 of the 1112 infants, resulting in a prevalence of 5.49/100 live births (95% confidence interval, 4.22- 6.99). Among the 80 anomalies identified, the organ systems involved included cardiovascular (n = 33), musculoskeletal (n = 15), renal (n = 9), genitourinary (n = 6), craniofacial (n = 4), and central nervous system (n = 2). First trimester exposure to efavirenz was associated with a significantly increased risk of congenital anomalies (odds ratio, 2.84; 95% confidence interval, 1.13-7.16). No significant associations were observed between exposure to other individual ARVs or classes of ARVs started at any time during pregnancy and infant congenital anomalies. Conclusions: The observed rate of congenital anomalies in this cohort is higher than previously reported for the general population, but it is consistent with rates observed in other recent studies of children born to human immunodeficiency virus-infected women. Cardiovascular anomalies occurred most frequently. With the exception of a known teratogen (efavirenz), no statistically significant associations between in utero exposure to ARVs and congenital anomalies were identified.

Original languageEnglish
Pages (from-to)164-170
Number of pages7
JournalPediatric Infectious Disease Journal
Volume31
Issue number2
DOIs
StatePublished - Feb 1 2012

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efavirenz
Mothers
HIV
Confidence Intervals
Teratogens
Live Birth
First Pregnancy Trimester
Clinical Protocols
Acquired Immunodeficiency Syndrome
Central Nervous System
Logistic Models
Odds Ratio
Regression Analysis
Clinical Trials
Guidelines
Pediatrics
Kidney
Safety
Pregnancy
Population

Keywords

  • Antiretroviral
  • Congenital anomalies
  • HIV
  • In utero exposure

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Infectious Diseases
  • Microbiology (medical)

Cite this

Knapp, K. M., Brogly, S. B., Muenz, D. G., Spiegel, H. M. L., Conway, D. H., Scott, G. B., ... Read, J. S. (2012). Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals. Pediatric Infectious Disease Journal, 31(2), 164-170. https://doi.org/10.1097/INF.0b013e318235c7aa

Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals. / Knapp, Katherine M.; Brogly, Susan B.; Muenz, Daniel G.; Spiegel, Hans M L; Conway, Daniel H.; Scott, Gwendolyn B; Talbot, Jeffrey T.; Shapiro, David E.; Read, Jennifer S.

In: Pediatric Infectious Disease Journal, Vol. 31, No. 2, 01.02.2012, p. 164-170.

Research output: Contribution to journalArticle

Knapp, KM, Brogly, SB, Muenz, DG, Spiegel, HML, Conway, DH, Scott, GB, Talbot, JT, Shapiro, DE & Read, JS 2012, 'Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals', Pediatric Infectious Disease Journal, vol. 31, no. 2, pp. 164-170. https://doi.org/10.1097/INF.0b013e318235c7aa
Knapp, Katherine M. ; Brogly, Susan B. ; Muenz, Daniel G. ; Spiegel, Hans M L ; Conway, Daniel H. ; Scott, Gwendolyn B ; Talbot, Jeffrey T. ; Shapiro, David E. ; Read, Jennifer S. / Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals. In: Pediatric Infectious Disease Journal. 2012 ; Vol. 31, No. 2. pp. 164-170.
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abstract = "Background: Although use of efficacious interventions, including antiretrovirals (ARVs), has dramatically reduced the rate of mother-to-child transmission of human immunodeficiency virus, the safety of in utero ARV exposure remains of concern. Methods: Data regarding 1112 infants enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025 born between 2002 and 2007 were analyzed for this study. Congenital anomalies were classified based on the Metropolitan Atlanta Congenital Defects Program guidelines. Associations between congenital anomalies and timing of first in utero exposure to ARVs were evaluated by logistic regression analysis. Results: Congenital anomalies were identified and confirmed in 61 of the 1112 infants, resulting in a prevalence of 5.49/100 live births (95{\%} confidence interval, 4.22- 6.99). Among the 80 anomalies identified, the organ systems involved included cardiovascular (n = 33), musculoskeletal (n = 15), renal (n = 9), genitourinary (n = 6), craniofacial (n = 4), and central nervous system (n = 2). First trimester exposure to efavirenz was associated with a significantly increased risk of congenital anomalies (odds ratio, 2.84; 95{\%} confidence interval, 1.13-7.16). No significant associations were observed between exposure to other individual ARVs or classes of ARVs started at any time during pregnancy and infant congenital anomalies. Conclusions: The observed rate of congenital anomalies in this cohort is higher than previously reported for the general population, but it is consistent with rates observed in other recent studies of children born to human immunodeficiency virus-infected women. Cardiovascular anomalies occurred most frequently. With the exception of a known teratogen (efavirenz), no statistically significant associations between in utero exposure to ARVs and congenital anomalies were identified.",
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